Quantitative C-arm Fluoroscopy - Prostate Brachytherapy

定量 C 形臂透视 - 前列腺近距离放射治疗

• 批准号: 7111285
• 负责人: EVERETTE C. BURDETTE
• 金额: $ 53.41万
• 依托单位: BURDETTE MEDICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-01 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7111285
• 关键词: anatomy; arm; clinical research; fluoroscopy; human; implant; performance; prostate; prostate neoplasms; ultrasound

DESCRIPTION (provided by applicant): Prostate cancer continues to be a significant health problem, both domestically and worldwide. Numerous studies have demonstrated the efficacy and safety of transperineal prostate brachytherapy in the therapy of prostate cancer. The success of brachytherapy chiefly depends on our ability to intra-operatively tailor the radiation dose to the patient's individual anatomy. Thus the objective of this research is to design, develop, and clinically test a method for intra-operative localization of the implanted seeds in relation to the prostate, to allow for intra-operative dosimetric optimization and exit dosimetry. Brachytherapy is predominantly performed with transrectal ultrasound guidance, which provides adequate real-time visualization of soft tissue anatomy, but does not show the implanted seeds. To overcome this problem, we propose registration of ultrasound to intra-operative C-arm fluoroscopy, where the implanted seeds will be reconstructed from fluoroscopy and superimposed on ultrasound. In particular, we will: (1) Design a system and workflow that is consistent with contemporary practice of prostate brachytherapy. (2) Develop optimized mathematical algorithms for reconstruction of seed implants from C-arm fluoroscopy images, spatial registration of fluoroscopy and ultrasound imaging. (3) Integrate the algorithms with an existing commercial prostate brachytherapy system and implant optimization methods. (4) Conduct Clinical System Performance Evaluation Trial on human patients. We have established the technical feasibility of this approach in a Phase-1 SBIR research grant. We are requesting Phase-2 support to develop a clinical-grade system and evaluate its technical performance on human patients. The resulting system will withstand the scrutiny of subsequent FDA approval and enter wide-spread clinical use via commercial dispersion.

描述（由申请人提供）：前列腺癌仍然是一个重大的健康问题，无论是在国内还是在世界范围内。大量的研究已经证明了经会阴前列腺近距离放射治疗前列腺癌的有效性和安全性。近距离放射治疗的成功主要取决于我们术中根据患者个体解剖结构调整放射剂量的能力。因此，本研究的目的是设计、开发和临床测试一种术中植入种子与前列腺相关的定位方法，以实现术中剂量学优化和术后剂量学。近距离放射治疗主要在经直肠超声引导下进行，它提供了足够的软组织解剖实时可视化，但不能显示植入的种子。为了克服这一问题，我们建议将超声与术中c臂透视登记，植入的种子将从透视重建并叠加在超声上。特别是，我们将：(1)设计一个与当代前列腺近距离治疗实践相一致的系统和工作流程。(2)开发优化的数学算法，用于从c臂透视图像重建种子植入物，透视和超声成像的空间配准。(3)将算法与现有的商用前列腺近距离治疗系统和植入物优化方法相结合。(4)对人体患者进行临床系统性能评价试验。我们已经在第一阶段SBIR研究资助中确定了这种方法的技术可行性。我们正在申请第二阶段支持，以开发临床级系统并评估其在人类患者中的技术性能。由此产生的系统将经得起随后FDA批准的审查，并通过商业分散进入广泛的临床应用。